galectin therapeutics inc (GALT) Key Developments
Galectin Therapeutics, Inc. Presents at 2nd Annual Growth Capital Expo, Apr-13-2015
Apr 6 15
Galectin Therapeutics, Inc. Presents at 2nd Annual Growth Capital Expo, Apr-13-2015 . Venue: Caesars Palace, Las Vegas, Nevada, United States.
Galectin Therapeutics, Inc. Reports Consolidated Earnings Results for the Year Ended December 31, 2014
Mar 18 15
Galectin Therapeutics, Inc. reported consolidated earnings results for the year ended December 31, 2014. The company reported fiscal year 2014 net loss applicable to common stockholders of $17.0 million, or $0.78 loss per basic and diluted share, compared with the prior year's $21.9 million, or $.30 loss per basic and diluted share. The company attributed the decrease in net loss applicable to common stockholders is largely due to an $8.8 million or $0.53 per share one-time, non-cash charge related to the modification of certain warrants recorded second quarter 2013 and an unrelated one-time, non-cash stock compensation charge of $1.0 million or $0.06 per share recorded in third quarter 2013, which were partially offset by increased research and development expenses primarily related to its clinical program. Total operating loss was $15.4 million against $12.1 million a year ago.
Galectin Therapeutics, Inc. announced delayed annual 10-K filing
Mar 16 15
On 03/16/2015, Galectin Therapeutics, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC.
Galectin Therapeutics Announces Details of Design of its Phase 2 Program With GR-MD-02
Feb 24 15
Galectin Therapeutics announced details of the design of its Phase 2 program with GR-MD-02 in patients with advanced fatty liver disease, or nonalcoholic steatohepatitis (NASH) with cirrhosis. The program includes two clinical studies. The first is a multicenter, randomized, placebo-controlled, double-blind, parallel-group Phase 2 trial to evaluate the safety and efficacy of GR-MD-02 for the treatment of liver fibrosis and resultant portal hypertension in patients with NASH cirrhosis (the NASH-CX trial). This trial is expected to commence in the second quarter of 2015 with data readout expected in the fourth quarter of 2017. In addition, the Company will conduct a smaller trial of shorter duration in NASH patients with advanced fibrosis (the NASH-FX trial). The NASH-CX trial was designed with guidance from the U.S. Food and Drug Administration (FDA) received during an End-of-Phase 1 meeting. The NASH-CX trial will include 45 sites (and up to 60 sites, if necessary) in the U.S. and Canada and will enroll a total of 156 patients. It will be comprised of three parallel treatment arms of 52 patients each, with one arm receiving 8 mg/kg of GR-MD-02, the expected therapeutic dose, one arm receiving 2 mg/kg of GR-MD-02 and a third arm receiving placebo. Patients will receive a total of 26 infusions every other week for one year and will be evaluated to determine the change in the hepatic venous pressure gradient (HVPG) as compared with placebo. The FDA has indicated that HVPG may serve as a surrogate primary endpoint for NASH cirrhosis. HVPG will be correlated with secondary endpoints of fibrosis on liver biopsy as well as with measurement of liver stiffness (FibroScan®) and assessment of liver metabolism (13C-methacetin breath test, Exalenz), which are non-invasive measures of the liver that may be used in future studies. Galectin is finalizing a submission to the FDA by the end of February for a Special Protocol Assessment (SPA) to accept this trial, if positive, as one of the required trials to support approval of the drug candidate. The FDA has previously agreed to review this study protocol for acceptance under an SPA.
Galectin Therapeutics, Inc. Presents at 27th Annual ROTH Conference, Mar-09-2015 11:00 AM
Feb 13 15
Galectin Therapeutics, Inc. Presents at 27th Annual ROTH Conference, Mar-09-2015 11:00 AM. Venue: The Ritz Carlton, 1 Ritz Carlton Dr, Dana Point, CA 92629, United States. Speakers: Harold H. Shlevin, Chief Operating Officer and Corporate Secretary.